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The Double Blind Placebo Controlled Trial
The blind allegiance to what I call the “fool's gold standard” lives on. Anyone with even a passing interest in bioethics knows it is unethical to conduct a double blind placebo controlled trial where standard therapy exists, except under limited circumstances. The exceptions are where: 1) there is no risk of harm if the patient forgoes treatment during the placebo phase such as in a trial for a drug that seeks to cure hair loss or impotence; 2) the standard therapy carries such severe side effects that patients might choose to avoid it; or 3) the standard therapy is otherwise of questionable efficacy. See, eg, Emanuel EJ, MD, PhD, Miller, FG, PhD: The Ethics of Placebo-Controlled Clinical Trials — A Middle Ground. N Engl J Med Vol. 345:915-919, (September 20, 2001), at http.//content.nejm.org/cgi/content/short/ 345/12/915?query=TOC; Hellman S: Of Mice But Not Men: Problems of the Randomized Clinical Trial. N Engl J Med, Vol 324 (May 30, 1991); Levine RJ: The Use of Placebos in Randomized Clinical Trials. IRB — A Review of Human Subject Research, Vol. 7, No.2, (March/April 1985); Bok S: The Ethics of Giving Placebos. Scientific American, Vol. 231, No. 5 (November 1974).
Still, sponsors and researchers continue to design and conduct such trials, providing the familiar excuse: “The FDA made us do it.” Indeed, in at least one case I have brought on behalf of an injured subject, I have seen the minutes of a meeting with an FDA official who advised the drug company that only a placebo controlled trial would be acceptable even though the drug company advised the official that standard therapy existed and there might be a risk of harm to the subject during the placebo phase. Even more startling is the response I have received in depositions of physician/principal investigators who believe such trials are the gold standard and are perfectly acceptable in the context of medical research as long as the subject signs the informed consent.
The Ethical Issues
Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
Legal Possession: What Does It Mean?
Possession of real property is a matter of physical fact. Having the right or legal entitlement to possession is not "possession," possession is "the fact of having or holding property in one's power." That power means having physical dominion and control over the property.
The Stranger to the Deed Rule
In 1987, a unanimous Court of Appeals reaffirmed the vitality of the "stranger to the deed" rule, which holds that if a grantor executes a deed to a grantee purporting to create an easement in a third party, the easement is invalid. Daniello v. Wagner, decided by the Second Department on November 29th, makes it clear that not all grantors (or their lawyers) have received the Court of Appeals' message, suggesting that the rule needs re-examination.